How to Develop Internal Monitoring How to Develop Internal Monitoring ProgramsPrograms

SEVENTHSEVENTH ANNUAL PHARMACEUTICAL ANNUAL PHARMACEUTICAL REGULATORYREGULATORY

AND COMPLIANCE CONGRESS AND BEST AND COMPLIANCE CONGRESS AND BEST PRACTICES FORUMPRACTICES FORUM

Stephen F. MohrStephen F. Mohr

Global Compliance Global Compliance Officer Officer

AstraZeneca AstraZeneca

Stanhope GateStanhope Gate

London, United KingdomLondon, United Kingdom44 (0)20-7304-512044 (0)20-7304-5120

Steve.Mohr@astrazeneca.comSteve.Mohr@astrazeneca.com

Keith M. KorenchukCovington & Burling LLP1201 Pennsylvania Avenue, N.W. Washington, D.C. 20004 (202) 662-5385kkorenchuk@cov.com

The views of the presenters are their own and do not necessarily reflect the positions or actions of their respective organizations.

An Overview of the Issues in An Overview of the Issues in DDevelopment of Internal Monitoring evelopment of Internal Monitoring

ProgramsPrograms

Stephen F. MohrStephen F. Mohr

Global Compliance Officer Global Compliance Officer

AstraZeneca AstraZeneca

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The Roadmap to an EffectiveThe Roadmap to an EffectiveMonitoring Program Monitoring Program

Identify areas for potential monitoringIdentify areas for potential monitoringDevelopment of areas of focus Development of areas of focus Budget supportBudget supportWritten protocolsWritten protocolsDevelopment and use of metrics Development and use of metrics Deployment of resourcesDeployment of resourcesUtilization of technologyUtilization of technologyEffectively communicating resultsEffectively communicating results

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Potential Challenges to Developing Potential Challenges to Developing an Effective Monitoring Function an Effective Monitoring Function Data qualityData qualitySystems integrationSystems integrationUnder-developed key performance Under-developed key performance indicatorsindicatorsFinancial resourcesFinancial resourcesHuman resources/staffingHuman resources/staffing

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Potential Challenges in Deployment Potential Challenges in Deployment of Resourcesof Resources

• Personnel issues in performing monitoring • Training of personnel• Communicating event indicators• Collaboration with HR/Legal• Follow-on investigations• Corrective Action

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Potential Challenges in Utilization Potential Challenges in Utilization of Technologyof Technology

• Real time monitoring• Transition issues• Dash Board Metrics• System Development and Integration• Vendor Performance

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Potential Challenges in Potential Challenges in Communicating Results to Communicating Results to

ManagementManagementEffective lines of communication between the Effective lines of communication between the compliance officer and senior management to compliance officer and senior management to communicate monitoring metrics and program communicate monitoring metrics and program performanceperformanceFocus on key performance indicatorsFocus on key performance indicatorsMetrics and nature of the reporting will evolve Metrics and nature of the reporting will evolve over time based upon the evolution of the over time based upon the evolution of the program in general and the sophistication of the program in general and the sophistication of the monitoring functionmonitoring function

A Closer Look: Developing Metrics A Closer Look: Developing Metrics and Approaches in Internal and Approaches in Internal

Monitoring ProgramsMonitoring Programs

Keith M. KorenchukCovington & Burling LLP

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Part 1: Potential Areas to be Part 1: Potential Areas to be Considered for Monitoring Considered for Monitoring

Government Price ReportingGovernment Price ReportingEngagement of Physicians (Consulting, Speaking Honoraria, Engagement of Physicians (Consulting, Speaking Honoraria, Preceptorships)Preceptorships)Clinical & Research Grants/StudiesClinical & Research Grants/StudiesContinuing Medical EducationContinuing Medical EducationMedical Affairs GuidelinesMedical Affairs GuidelinesSamplesSamplesFree GoodsFree GoodsPatient Assistance Program/Indigent Patient ProgramsPatient Assistance Program/Indigent Patient ProgramsDebt Forgiveness/ReductionDebt Forgiveness/ReductionContractual Payments (Discounts, Rebates, Admin. Fees)Contractual Payments (Discounts, Rebates, Admin. Fees)

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Potential Areas to be Considered Potential Areas to be Considered for Monitoring (continued)for Monitoring (continued)

Conventions/Symposia/FoundationsConventions/Symposia/FoundationsData PurchasesData PurchasesNon-clinical GrantsNon-clinical GrantsValue-Added ProgramsValue-Added ProgramsGifts, Meals, And EntertainmentGifts, Meals, And EntertainmentPromotional Materials/Sales AidsPromotional Materials/Sales AidsOff-Label PromotionOff-Label PromotionPrivacyPrivacyData IntegrityData IntegrityGXP/FDA Related IssuesGXP/FDA Related IssuesPublication of Clinical DataPublication of Clinical Data

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Part 2: Development of Areas of Part 2: Development of Areas of FocusFocus

Risk matrix Risk matrix Use of surveysUse of surveysInternal assessmentsInternal assessmentsGovernment enforcement effortsGovernment enforcement effortsAbility to monitor-technology and Ability to monitor-technology and resourcesresources

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Part 3: Budget Support and Part 3: Budget Support and Allocation of ResourcesAllocation of Resources

Priority of monitoring in the Priority of monitoring in the compliance contextcompliance contextAllocation of resources Allocation of resources Funding supportFunding supportCapital and operating commitmentsCapital and operating commitments

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Part 4: Written ProtocolsPart 4: Written Protocols

Develop written protocols for the Develop written protocols for the monitor function.monitor function.Training of staff on monitoring functionTraining of staff on monitoring functionEstablish framework for assessment Establish framework for assessment of monitor program operationof monitor program operation

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Part 5: Development of MetricsPart 5: Development of Metrics

Within areas of focus identify key data needsWithin areas of focus identify key data needsFashion approach based upon measurement Fashion approach based upon measurement capabilitiescapabilitiesDevelopment of metrics is context specificDevelopment of metrics is context specificUtilize metrics that can provide notice of the Utilize metrics that can provide notice of the need for further reviewneed for further reviewUtilize results to achieve compliance Utilize results to achieve compliance program goals program goals Use results to communicate program activityUse results to communicate program activity

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Possible Metrics to be Considered Possible Metrics to be Considered for Monitoring Dissemination of for Monitoring Dissemination of

Scientific Information Scientific Information

Requests or inquires related to off-label uses of Requests or inquires related to off-label uses of productsproductsSales call notesSales call notesVerbatimsVerbatimsDrug sampling recordsDrug sampling recordsApproved promotional materialsApproved promotional materialsBusiness/strategic plansBusiness/strategic plans

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Possible Metrics to be Considered Possible Metrics to be Considered for Monitoring Engagement of for Monitoring Engagement of

Physicians Physicians Number of consultants retained per productNumber of consultants retained per productNumber of speakers retained per productNumber of speakers retained per productUtilization of speakers who attend speaker Utilization of speakers who attend speaker trainingtrainingDirect payments to physiciansDirect payments to physiciansIndirect (via vendor) payments to physiciansIndirect (via vendor) payments to physiciansProgram design and content of advisory boardsProgram design and content of advisory boards

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Possible Metrics to be Considered Possible Metrics to be Considered for Sales Representative/MSL for Sales Representative/MSL

Monitoring Monitoring Identifying potential off-label promotional Identifying potential off-label promotional activity by sales representatives/MSLs activity by sales representatives/MSLs through observations of the interactions through observations of the interactions with Health Care Professionals.with Health Care Professionals.Conduct full-day, potentially random, direct Conduct full-day, potentially random, direct inspections and observations of the inspections and observations of the messages and materials delivered by sales messages and materials delivered by sales representatives/MSLs. representatives/MSLs.

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Possible Metrics to be Considered Possible Metrics to be Considered for Sales Representative/MSL for Sales Representative/MSL

Monitoring (cont’d)Monitoring (cont’d)Number of inspections conducted proportional in Number of inspections conducted proportional in number to the size of the sales force/MSLs number to the size of the sales force/MSLs Inspections conducted across all regions where Inspections conducted across all regions where the company operates.the company operates.Inspection report prepared by compliance Inspection report prepared by compliance personnel to include: personnel to include: – the identify of the sales reps/MSLs; the identify of the sales reps/MSLs; – the identity of the monitor; the identity of the monitor; – the date and duration of the inspection; the date and duration of the inspection; – the topics discussed during the inspection; and the topics discussed during the inspection; and – identification of any potential off-label promotional identification of any potential off-label promotional

activity by the sales rep/MSL.activity by the sales rep/MSL.

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Possible Metrics to be Considered Possible Metrics to be Considered for Monitoring and Review of for Monitoring and Review of

Requests for Off-Label InformationRequests for Off-Label InformationAnalyze sales representative/MSL submitted off-Analyze sales representative/MSL submitted off-label inquiries.label inquiries.Compile and provide information about all Compile and provide information about all requests submitted to the Medical Information Unit requests submitted to the Medical Information Unit by sales representatives/MSLs about products.by sales representatives/MSLs about products.Request information should be separated by Request information should be separated by therapy area and/or producttherapy area and/or productData analyzed to identify those sales Data analyzed to identify those sales representatives/MSLs associated with the highest representatives/MSLs associated with the highest number of requests for information.number of requests for information.

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Possible Metrics for Monitoring and Possible Metrics for Monitoring and Review of Requests for Off-Label Review of Requests for Off-Label

Information (cont’d)Information (cont’d)For each therapy area, review further the requests For each therapy area, review further the requests and resulting responses from a certain number of and resulting responses from a certain number of sales rep/MSLs with the largest number of requests.sales rep/MSLs with the largest number of requests.Information related to the Medical Information Information related to the Medical Information requests for the top number of requestors in the requests for the top number of requestors in the therapy area is reviewed.therapy area is reviewed.A formal investigation is conducted and disciplinary A formal investigation is conducted and disciplinary action undertaken where appropriate in the event that action undertaken where appropriate in the event that the analysis and review indicates that an MSL may the analysis and review indicates that an MSL may have inappropriately caused the dissemination of off-have inappropriately caused the dissemination of off-label information or engaged in off-label promotion.label information or engaged in off-label promotion.

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Possible Metrics: Message Recall Possible Metrics: Message Recall Monitoring ProgramMonitoring Program

Message Recall Monitoring Program designed to Message Recall Monitoring Program designed to identify potential off-label promotional activities by identify potential off-label promotional activities by sales representatives /MSLs through the analysis sales representatives /MSLs through the analysis of commercially available, non-company messages of commercially available, non-company messages delivered by sales representatives/MSLs (Message delivered by sales representatives/MSLs (Message Recall Studies)Recall Studies)Obtain Message Recall Studies relating to several Obtain Message Recall Studies relating to several products products Analyze the results of all Message Recall Studies Analyze the results of all Message Recall Studies to determine whether they reveal any indicators of to determine whether they reveal any indicators of potential off-label promotional activitiespotential off-label promotional activities

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Total Spend Monitoring: the Holy Total Spend Monitoring: the Holy Grail?Grail?

Total spend requirements under State Total spend requirements under State law evolvinglaw evolvingChanging standards and calculationsChanging standards and calculationsCapturing data across the enterpriseCapturing data across the enterpriseQuality of dataQuality of dataReporting timelinessReporting timeliness

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Other Metrics to be ConsideredOther Metrics to be Considered

• Government Price Reporting • Clinical & Research Grants/Studies• Continuing Medical Education• Samples• Free Goods• Patient Assistance Program/Indigent Patient Programs• Debt Forgiveness/Reduction• Contractual Payments (Discounts, Rebates, Admin. Fees)• Conventions/Symposia/Foundations

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Other Metrics to be Considered Other Metrics to be Considered (continued)(continued)

• Data Purchases• Non-clinical Grants• Value-Added Programs• Gifts, Meals, And Entertainment• Promotional Materials/Sales Aids• Privacy• Data Integrity• Publication of Clinical Data

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Questions/DiscussionQuestions/Discussion